OncoMatch/Clinical Trials/NCT07089992
A Study of Pembrolizumab in People With Ultra-Rare Sarcomas
Is NCT07089992 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for sarcoma.
Treatment: Pembrolizumab — The purpose of the study is to find out if pembrolizumab is a useful treatment that causes few or mild side effects in people with ultra-rare sarcoma. The researchers will also study how the immune system responds to the study treatment. Pembrolizumab is a type of drug called a PD-1 inhibitor. It is designed to block a protein called programmed cell death protein 1 (PD-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Metastatic disease required
Patient should have recurrent or metastatic disease not judged to be curable with other means; Measurable disease as per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anti-cancer therapy
Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Cannot have received: systemic anti-cancer therapy
No prior systemic anti-cancer therapy including investigational agents within 4 weeks, 2 weeks for kinase inhibitors or intravenous chemotherapy, prior to starting therapy on study
Cannot have received: investigational agent
No investigational agent(s) administration or use of investigational device within 4 weeks prior to study intervention administration.
Cannot have received: radiotherapy
Exception: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
No prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 9 g/dl
Kidney function
Liver function
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert disease who have bilirubin level ≤ 3 x ULN may be enrolled); AST and ALT ≤3 x institutional ULN
Cardiac function
Adequate cardiac function, defined as: class II or better New York Heart Association (NYHA) Functional Classification.
Required organ function (specimens to be collected within 14 days of the start of the study intervention): Adequate hematologic function, defined as: Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 9 g/dl. Adequate renal function defined, as: Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert disease who have bilirubin level ≤ 3 x ULN may be enrolled); AST and ALT ≤3 x institutional ULN. Adequate cardiac function, defined as: class II or better New York Heart Association (NYHA) Functional Classification.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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